Roche Diagnostics Operations, Inc. - ACCUCHEK - Class 2 Recall
ACCU-CHEK Aviva Combo Blood Glucose Meter (as a part of the ACCU-CHEK Aviva Combo System)\ The ACCU-CHEK Combo System is indicated for the treatment of insulin-requiring diabetes and for the quantitative measurement of glucose in fresh capillary whole blood from the finger. (Source: Medical Device Recalls)
Source: Medical Device Recalls - November 23, 2013 Category: Medical Equipment Source Type: alerts
Insulet Corporation - OmniPod Insulin Management System Starter Kit - Class 2 Recall
OmniPod Insulin Management System Starter Kit; Model Reference Number: SKT-UST400 (Starter Kit) Product Usage: The Starter Kit (SKT-UST400) is provided to users as an introduction to the OmniPod Insulin Management System prior to initiating care. It includes the Personal Diabetes Manager (PDM) with two AAA alkaline batteries, a USB cable, a User s Guide, a Soft Carrying Case, a Troubleshooting guide, a Warranty Registration Card, and two Alcohol Pads. The OmniPod Insulin Management System is intended for subcutaneous delivery of insulin at set and variable rates for the management of diabetes mellitus in persons requir...
Source: Medical Device Recalls - November 6, 2013 Category: Medical Equipment Source Type: alerts
Insulet Corporation - OmniPod Insulin Management Product Demonstration Kit - Class 2 Recall
OmniPod Insulin Management Product Demonstration Kit; Model Reference Number: (PDK-ZXP490) Product Usage: The Demonstration Kit (PDK-ZXP490) is an alternate kit provided to potential patients by healthcare professionals for patients to experience what wearing a Pod may feel like prior to purchase. Each Demonstration Kit includes a UST400 brochure, one Alcohol Pad, and a Pod. The OmniPod Insulin Management System is intended for subcutaneous delivery of insulin at set and variable rates for the management of diabetes mellitus in persons requiring insulin and for the quantitative measurement of glucose in fresh whole cap...
Source: Medical Device Recalls - November 6, 2013 Category: Medical Equipment Source Type: alerts
Bayer Healthcare Llc - Bayer brand A1CNow MULTITEST A1C SYSTEM TEST KITS - Class 2 Recall
Bayer brand A1CNow+ MULTI-TEST A1C SYSTEM TEST KITS (PART NUMBER 3021/08842610); Hemoglobin A1c Monitor; Glycosylated Hemoglobin Assay; Product is manufactured and distributed by Bayer HealthCare LLC, Sunnyvale, CA The A1CNow+ test provides quantitative measurement of the percent of glycated hemoglobin (%HbA1c or %A1C) levels in capillary (fingerstick) or venous whole blood samples. The test is for professional use to monitor glycemic control in people with diabetes. (Source: Medical Device Recalls)
Source: Medical Device Recalls - November 3, 2013 Category: Medical Equipment Source Type: alerts
HemoCue AB - HemoCue Glucose 201 Microcuvettes - Class 2 Recall
HemoCue¿ Glucose 201 Microcuvettes, 25 Microcuvettes Individually Packaged. The HemoCue Glucose 201 Microcuvettes are designed for use with the HemoCue Glucose 201 Analyzer and the HemoCue Glucose 201 DM Analyzer. Quantitative determination of glucose in whole blood using a specially designed analyzer, the HemoCue Glucose 201 with Plasma conversion. The quantitative determination of the instant blood glucose concentration in circulation supplements the clinical evidence in the diagnosis and treatment of patients with diabetes as well as monitoring of neonatal blood glucose levels. (Source: Medical Device Recalls)
Source: Medical Device Recalls - September 12, 2013 Category: Medical Equipment Source Type: alerts
Nova Biomedical Corporation - Nova Max Glucose Test Strips - Class 1 Recall
Nova Max Glucose Test Strips (50 Count Retail) Catalog Number: 43437 Product Usage: The Nova Max Glucose Test Strips are for use with the Nova Max Family of Glucose Monitors (Nova Max, Nova Max Plus, Nova Max Link, BD Logic and Paradigm Link). These monitors are intended to be used for the quantitative measurement of glucose in fresh capillary whole blood. They are intended for use by people with diabetes mellitus in the home and by healthcare professionals in clinical settings as an aid to monitor the effectiveness of diabetes control (Source: Medical Device Recalls)
Source: Medical Device Recalls - August 10, 2013 Category: Medical Equipment Source Type: alerts
Nova Biomedical Corporation - Nova Max Glucose Test Strips - Class 1 Recall
Nova Max Plus Monitor System (Kit w/10 Count Vials International) Catalog Number: 45507 Product Usage: The Nova Max Glucose Test Strips are for use with the Nova Max Family of Glucose Monitors (Nova Max, Nova Max Plus, Nova Max Link, BD Logic and Paradigm Link). These monitors are intended to be used for the quantitative measurement of glucose in fresh capillary whole blood. They are intended for use by people with diabetes mellitus in the home and by healthcare professionals in clinical settings as an aid to monitor the effectiveness of diabetes control (Source: Medical Device Recalls)
Source: Medical Device Recalls - August 10, 2013 Category: Medical Equipment Source Type: alerts
Nova Biomedical Corporation - Nova Max Glucose Test Strips - Class 1 Recall
Nova Max Glucose Test Strips (10 Count Boxed) Catalog Number: 43590 Product Usage: The Nova Max Glucose Test Strips are for use with the Nova Max Family of Glucose Monitors (Nova Max, Nova Max Plus, Nova Max Link, BD Logic and Paradigm Link). These monitors are intended to be used for the quantitative measurement of glucose in fresh capillary whole blood. They are intended for use by people with diabetes mellitus in the home and by healthcare professionals in clinical settings as an aid to monitor the effectiveness of diabetes control (Source: Medical Device Recalls)
Source: Medical Device Recalls - August 10, 2013 Category: Medical Equipment Source Type: alerts
